GENEPATH DIAGNOSTICS INDIA PRIVATE · 89-08 · INDIA
For GENEPATH DIAGNOSTICS INDIA PRIVATE, import alert is 89-08; country is INDIA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is GenePath CoViSwift v3.0; product code is 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid; date published is 11/24/2021; address is Above Phadkehospital , 4th Floor; Jangli Maharaj Road , Pune, Maharashtra INDIA, verified against its source on 2026-09-30.
- Firm
- GENEPATH DIAGNOSTICS INDIA PRIVATE verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- INDIA verified
- Address
- Above Phadkehospital , 4th Floor; Jangli Maharaj Road , Pune, Maharashtra INDIA verified
- Date published
- 11/24/2021 verified
- Product code
- 83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid verified
- Product
- GenePath CoViSwift v3.0 verified
What the source says
GENEPATH DIAGNOSTICS INDIA PRIVATE Date Published : 11/24/2021 Above Phadkehospital , 4th Floor; Jangli Maharaj Road , Pune, Maharashtra INDIA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
83 Q - - JR Reagents, 2019-novel coronavirus nucleic acid Date Published: 11/24/2021 Desc: GenePath CoViSwift v3.0
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html